Notice Type
Departmental
Notice Title

Consent to the Distribution of a New Medicines

Pursuant to section 20 of the Medicines Act 1981, the Minister of Health hereby consents to the distribution in New Zealand of the new medicines which were referred to the Minister of Health under the provisions of section 24(5) of the Act and are set out in the Schedule hereto:

Schedule

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Keytruda
Pembrolizumab 50mg
Powder for infusion
Merck Sharp & Dohme (New Zealand) Limited
Schering-Plough Company, Innishannon, Ireland

Note: The application received 1 November 2016 is for the melanoma indication.

Product:
Active Ingredient:
Dosage Form:
New Zealand Sponsor:
Manufacturer:

Keytruda
Pembrolizumab 50mg
Powder for infusion
Merck Sharp & Dohme (New Zealand) Limited
Schering-Plough Company, Innishannon, Ireland

Note: The application received 24 February 2017 is for the previously treated non-small cell lung carcinoma indication.

Dated this 12th day of May 2017.

CHRIS JAMES, Group Manager, Medsafe, Ministry of Health (pursuant to delegation given by the Minister of Health on 11 September 2013).